Acute Ischemic Stroke
Conditions
Brief summary
Post-Market Registry
Detailed description
An observational, prospective, multi-center, single-arm registry to provide continuing evaluation of safety and effectiveness of Medtronic Neurovascular commercially available products used in the treatment of acute ischemic stroke.
Interventions
Index stroke procedure and follow-up visits up to 90 days post index procedure
Sponsors
Study design
Eligibility
Inclusion criteria
1. Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements. 2. Participant is treated or intended to be treated with a commercially available Medtronic Neurovascular device\* during treatment for acute ischemic stroke. 3. Participant is 18 years of age or older.
Exclusion criteria
1. Participant who may be unable to complete follow-up within the registry. 2. Participant of child-bearing potential who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study. 3. Participant is currently enrolled in, or plans to enroll in, any concurrent drug/device study that may confound the study results based on Principal Investigator's discretion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate device safety | From Day 0 to 90 days post-procedure | Incidence of Safety Events of Interest through 90-day follow-up |
| Evaluate device performance | Day 0 - end of index stroke procedure | Reperfusion defined as eTICI ≥2b50; ≥2b67; ≥2c; =3 at end of procedure. |
| Evaluate device effectiveness | From Day 0 to 90 days post-procedure | Functional independence as measured by modified Rankin Scale (mRS) score ≤ 2 at 90-day follow up (mRS scores range from 0 \[no symptoms\] to 6 \[death\]). |
Countries
United States